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Novartis Pharmaceuticals agrees to pay $422.5 million for off-label marketing

October 01, 2010

Novartis Pharmaceuticals Corporation has agreed to pay $422.5 million in two separate settlements resulting from their alleged off-label drug marketing. According to the accusation, Novartis profited by “hundreds of millions of dollars” through their off-label promotion of Trileptal. Trileptal is a drug FDA approved for treatment of epilepsy patients, although Novartis has been accused of promoting its use for a number of other ailments and conditions.

The allegations, which Novartis has agreed to plea guilty to, contend that Novartis actively used kick-backs and other financial and gift inducements to encourage doctors to prescribe Trileptal, as well as other Novartis drugs. “Unlawful off-label promotion and providing illegal inducements to health care professionals undermine the integrity of our health care system and we will continue to pursue these types of violations,” stated Tony West Assistant Attorney General for the Civil Division of the Department of Justice.

If Novartis’s guilty plea and sentence are accepted by the court, Novartis will pay a criminal fine and forfeiture of $185 million. Additionally, it will pay $237.5 million to resolve allegations that it caused Medicare and other Federal programs to pay for Novartis drugs under fraudulent circumstance. This will additionally settle four whistleblower cases filed by former Novartis employees, who will share $25,675,035 of the Federal recovery.

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